MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 801074

Device Problems Leak/Splash (1354); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The service repair technician (srt) observed this during the installation of the o2 sensor.He replaced the o2 sensor.The unit operated to the manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) was not able confirm a leak.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

Event Description

Upon receipt of the device, the user reported that the oxygen (o2) sensor was leaking.There was no patient involvement.

Manufacturer Narrative

Per follow up with the service repair technician (srt), the sensor was wiped off and tightened to prevent further leaking.

Manufacturer Narrative

(b)(4).The reported complaint was confirmed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer Contact: katie hoyt ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 6811306
• MDR Text Key: 83532384
• Report Number: 1828100-2017-00377
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/18/2017
• Device Model Number: 801074
• Device Catalogue Number: 801074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 12/05/2017; 01/12/2018
• Supplement Dates FDA Received: 12/22/2017; 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1